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Nucleos(t)ide analogue
RO7565020 for Chronic Hepatitis B
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests a new drug called RO7565020 to see if it is safe and how it behaves in the body. It includes healthy people and those with chronic hepatitis B. Researchers aim to understand how the drug moves through and affects the body.
Who is the study for?
This trial is for healthy adults or those with chronic hepatitis B (CHB) who have a BMI of 18-32 kg/m^2. CHB participants must have been positive for HBsAg for at least 6 months and on NUC therapy for over a year without signs of advanced liver disease. People with cirrhosis, suspected cancer, or other significant diseases are excluded.
What is being tested?
The study tests RO7565020's safety and effects in humans compared to a placebo. It's the first time this drug is being tried in people. The trial will gradually increase doses to find safe levels and see how the body reacts over single or multiple doses in both healthy individuals and those with suppressed CHB.
What are the potential side effects?
Since this is an early-phase trial, specific side effects of RO7565020 aren't fully known yet. However, potential risks may include reactions at the injection site, flu-like symptoms, nausea, fatigue, headache, and possible liver-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RO7565020Experimental Treatment2 Interventions
Group II: PlaceboPlacebo Group1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Hepatitis B (CHB) include antiviral medications like entecavir and tenofovir, which inhibit the hepatitis B virus (HBV) DNA polymerase, thereby preventing viral replication. Pegylated interferon works by enhancing the immune response to HBV, promoting the clearance of infected cells.
These mechanisms are crucial for CHB patients as they help reduce viral load, minimize liver damage, and lower the risk of liver cirrhosis and hepatocellular carcinoma. Investigational drugs like RO7565020 are being studied to further improve safety, tolerability, and efficacy, potentially offering new therapeutic options for better management of CHB.
[Clinical considerations in the design of clinical trial for innovative hepatitis B drugs].Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials.Liver safety assessment in clinical trials of new agents for chronic hepatitis B.
[Clinical considerations in the design of clinical trial for innovative hepatitis B drugs].Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials.Liver safety assessment in clinical trials of new agents for chronic hepatitis B.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,460 Previous Clinical Trials
1,097,789 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,230 Previous Clinical Trials
897,144 Total Patients Enrolled